ISRCTN42318360已完成不适用
The efficacy of the combination of allergen vaccination and vitamin D3 in the reduction of allergen-specific nasal responses. A placebo controlled trial.
Academic Medical Centre (AMC) (Netherlands)0 个研究点目标入组 90 人开始时间: 2006年1月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with rhinoconjunctivitis with or without mild asthma for at least 2 years. Their allergic symptoms should be related to the grass-pollen season.
- •2. A positive skin prick test for grass, minimally HEP 1
- •3. Positive reaction to intranasal challenge with grass-pollen
- •4. Age between 18 and 65
- •5. Patients with a written informed consent
- •Note: Patients with concomitant sensitisation to perennial allergens like house dust mite and pets can be included as long as they do not reveal clinical symptoms or only at very rare occasional exposure. In case of sensitisation to pets, these pets should not be present at home.
排除标准
- •1. Use of corticosteroids (systemic and local) outside grass-pollen season (May-July)
- •2. Serious immunopathologic diseases or malignancies (including auto-immune diseases, tuberculosis)
- •3. Severe asthma or emphysema, based on questionnaire; use of inhaled corticosteroids
- •4. Chronic symptoms related to concomitant sensitisation to other perennial allergens like pets or mites
- •5. Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension
- •6. Diseases with a contra-indication for the use of adrenaline
- •7. Severe kidney disease
- •8. Treatment with beta-blockers or ACE inhibitors or immunosuppressive drugs
- •9. Severe atopic dermatitis
- •10. Immunotherapy (including sublingual) treatment with grass-pollen within the last 5 years
- •11. Pregnancy, lactation or inadequate contraceptive measures
- •12 Alcohol or drug abuse
- •13. Lack of co-operation or severe psychological disorders
研究者
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The efficacy of the combination of allergen vaccination and Vitamin D3 in the reduction of allergen-specific nasal responses. A placebo controlled trial.allergic rhinitisNL-OMON28331Prof. dr. W.J. Fokkens, ENT surgeonDepartment of Otorhinolaryngology,Room A2-234, Academic Medical Center, AmsterdamW.J.Fokkens@amc.nlphone: +31 20 5663789fax: +31 20 566957390
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